EUS Guided Liver Biopsy - Will it Give Better Yield, More Tissue With Less Complication?

Asian Institute of Gastroenterology, India

Status: Completed

Conditions: Alcoholic Hepatitis; NAFLD

Treatments: Device: Endoscopic USG guided Liver biopsy; Device: Percutaneous Liver Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04235855

ECR/346/Inst/AP/2013/RR-19

Details and patient eligibility

About

Liver biopsy would be done by Endoscopic Ultrasound using Acquire needle.

Full description

In this study, we aim to evaluate the tissue adequacy of EUS guided liver biopsy for parenchymal liver disease and to evaluate if diagnostic yield of left lobe is non-inferior to right lobe biopsies and to assess if combination biopsies have better yield than single lobe biopsies. Safety of the procedure and technical success would be noted.

The data would be analysed using SPSS software and needful variables and tests would be used as per statistical requirement.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of any undiagnosed hepatic disease (after extensive investigation - serological as well as imaging) requiring a liver biopsy
• Patients of NAFLD who need liver biopsy
• Alcoholic hepatitis patients needing biopsy
• Any patient with unexplained transaminesemia > 1.5 times ULN needing a liver biopsy as advised by Hepatologist

Exclusion criteria

• Any liver Space occupying lesion suspicious of malignancy
• Platelet count <80,000
• INR > 1.5
• Pregnancy
• Severe cardiovascular and pulmonary diseases
• Recent use of anti-platelet agents within 5 days of the procedure
• Unwilling to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Endoscopic USG guided Liver biopsy

Experimental group

Description:

Olympus linear echo endoscope (GF -UCT 180, Olympus Ltde, Tkyo, Japan) will be used. 19 Gz EUS Acquire needle Boston ©Scientific Corp will be used for liver tissue acquisition.

Treatment:

Device: Endoscopic USG guided Liver biopsy

Percutaneous Liver biopsy

Active Comparator group

Description:

All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield .

Treatment:

Device: Percutaneous Liver Biopsy